Escalating Monthly Doses of Tafenoquine in Healthy Volunteers
Status:
Not yet recruiting
Trial end date:
2022-12-03
Target enrollment:
Participant gender:
Summary
In 2018, the U.S. Food and Drug Administration (FDA) and the Australian Therapeutic Goods
Administration (TGA) approved tafenoquine for malaria prevention. The approved tafenoquine
prophylactic regimen is 600 mg loading dose (200 mg daily for 3 days) prior to travel and a
weekly 200 mg maintenance dose commencing 7 days after the last loading dose. This weekly
tafenoquine regimen is more convenient with potentially improved compliance than daily
doxycycline or atovaquone proguanil (Malarone), the other recommended prophylactic agents by
the U.S. Centers for Disease Control and Prevention (CDC) for the prevention of malaria
infections.
Current assumptions are that a systemic minimum inhibitory concentration (MIC) of tafenoquine
in plasma is 80 ng/mL in nonimmune individuals is required to prevent symptomatic
breakthroughs of malaria infections. Because of tafenoquine's lengthy blood elimination
half-life of 2-3 weeks, a monthly regimen of 600 mg and 800 mg of tafenoquine in individuals
weighing 60 kg and 80 kg, respectively, have pharmacokinetic (PK) profiles (i.e., drug
concentration versus time curves) of achieving MIC values of at least 80 ng/mL in the
majority of healthy individuals. The aim of this study is to determine whether the safety and
tolerability profiles in healthy participants taking monthly doses of 600 mg or 800 mg
tafenoquine are comparable in the same participants taking weekly 200 mg tafenoquine.
Study Hypothesis: The study hypothesis is that the frequency of tafenoquine-related safety
(e.g. blood chemistries) and adverse events (AEs) in healthy participants who take a higher
dose (600 mg and 800 mg) of tafenoquine monthly would be comparable to the frequency of
treatment related safety and AEs in the same individuals who take weekly tafenoquine (200
mg).
Phase:
Phase 4
Details
Lead Sponsor:
Naval Medical Research Center
Collaborators:
Australian Defence Force Malaria and Infectious Disease Institute (ADF MIDI) Naval Environmental Preventive Medicine Unit TWO (NEPMU-2) Naval Medical Research Unit TWO (NAMRU-2) The 108 Military Central Hospital